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N Engl J Med. 2019 Jun 27;380(26):2541-2550. doi: 10.1056/NEJMsa1901109. Epub 2019 Apr 3.

Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement.

Author information

1
From the Division of Cardiology, Duke University Medical Center (S.V.), the Duke Clinical Research Institute (S.V., Z.L., D.D., A.S.K.), and the Department of Biostatistics and Bioinformatics, Duke University (A.S.K.) - all in Durham, NC; the Division of Cardiology, Department of Medicine, University of Colorado, Aurora (J.D.C.); Baylor Scott and White Heart Hospital, Plano (M.J.M.), and the Division of Cardiology, Department of Medicine, University of Texas Southwestern Medical Center, Dallas (D.J.K.) - both in Texas; the Division of Cardiology, Hackensack Meridian School of Medicine at Seton Hall University, Hackensack, NJ (C.E.R.); the Division of Cardiothoracic Surgery, Medstar Heart and Vascular Institute and Georgetown University, Washington, DC (V.H.T.); the Division of Cardiology, William Beaumont Hospital, Royal Oak, MI (G.H.); the University of Pittsburgh School of Medicine, Pittsburgh (T.G.G.); the Divisions of Cardiology (H.C.H.) and Cardiothoracic Surgery (J.E.B.), University of Pennsylvania, Philadelphia; and the Philip R. Lee Institute of Health Policy Studies, University of California, San Francisco, San Francisco (R.G.B.).

Abstract

BACKGROUND:

During the introduction of transcatheter aortic-valve replacement (TAVR) in the United States, requirements regarding procedural volume were mandated by the Centers for Medicare and Medicaid Services as a condition of reimbursement. A better understanding of the relationship between hospital volume of TAVR procedures and patient outcomes could inform policy decisions.

METHODS:

We analyzed data from the Transcatheter Valve Therapy Registry regarding procedural volumes and outcomes from 2015 through 2017. The primary analyses examined the association between hospital procedural volume as a continuous variable and risk-adjusted mortality at 30 days after transfemoral TAVR. Secondary analysis included risk-adjusted mortality according to quartile of hospital procedural volume. A sensitivity analysis was performed after exclusion of the first 12 months of transfemoral TAVR procedures at each hospital.

RESULTS:

Of 113,662 TAVR procedures performed at 555 hospitals by 2960 operators, 96,256 (84.7%) involved a transfemoral approach. There was a significant inverse association between annualized volume of transfemoral TAVR procedures and mortality. Adjusted 30-day mortality was higher and more variable at hospitals in the lowest-volume quartile (3.19%; 95% confidence interval [CI], 2.78 to 3.67) than at hospitals in the highest-volume quartile (2.66%; 95% CI, 2.48 to 2.85) (odds ratio, 1.21; P = 0.02). The difference in adjusted mortality between a mean annualized volume of 27 procedures in the lowest-volume quartile and 143 procedures in the highest-volume quartile was a relative reduction of 19.45% (95% CI, 8.63 to 30.26). After the exclusion of the first 12 months of TAVR procedures at each hospital, 30-day mortality remained higher in the lowest-volume quartile than in the highest-volume quartile (3.10% vs. 2.61%; odds ratio, 1.19; 95% CI, 1.01 to 1.40).

CONCLUSIONS:

An inverse volume-mortality association was observed for transfemoral TAVR procedures from 2015 through 2017. Mortality at 30 days was higher and more variable at hospitals with a low procedural volume than at hospitals with a high procedural volume. (Funded by the American College of Cardiology Foundation National Cardiovascular Data Registry and the Society of Thoracic Surgeons.).

PMID:
30946551
DOI:
10.1056/NEJMsa1901109
[Indexed for MEDLINE]

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